FDA 510(k) Application Details - K021585

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K021585
Device Name Light, Surgical, Ceiling Mounted
Applicant SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS, MI 49512 US
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Contact KARI OGREEN
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 05/14/2002
Decision Date 11/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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